# K261647: Tempo Plating System; Ultra Compression Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Pace Surgical
- Decided: Sep 3, 2026 after 107 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K962616 (1996). 132 ancestors in all.
No later device cites it as a predicate yet.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250952: Baby Gorilla®/Gorilla® Plating System, Paragon 28, Inc. (2025) Summary page 7.
- K251555: Ultra™ Compression Screw System, Pace Surgical (2025) Summary page 7.
- K203011: Monster Screw System, Paragon 28, Inc. (2020) Summary page 7.

## Indications for use
The Tempo Plating System is indicated for use in stabilization and fixation of fractures or osteotomies; intra- and extra-articular fractures, joint depression, and multifragmentary fractures; revision procedures, joint fusion, and reconstruction of small bones of the toes, feet, and ankles, including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The system can be used in adult patients. Specific examples include: Forefoot: • Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion) • Metatarsal or phalangeal fractures and osteotomies • Lesser metatarsal fractures (e.g. Weil) • Fifth metatarsal fractures (e.g. Jones Fracture) M id/H indfoot: • LisFranc Arthrodesis and/or Stabilization • 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions • lntercuneiform Fusions • Navicular-Cuneiform (NC) Fusion • Talo-Navicular (TN) Fusion • Calcaneo-Cuboid (CC) Fusion • Subtalar Fusion • Medial Column Fusion • Cuneiform Fracture • Cuboid Fracture • Navicular Fracture First metatarsal osteotomies for hallux valgus correction, including: • Opening base wedge osteotomy • Closing base wedge osteotomy • Crescentic Osteotomy • Proximal Osteotomy (Chevron and Rotational Oblique) • Distal Osteotomy (Chevron / Austin) Arthrodesis of the first metatarsophalangeal joint (MTP), including: • Primary MTP Fusion due to hallux ridgidus and/or hallux valgus • Revision MTP Fusion • Revision of failed first MTP Arthroplasty implant Flatfoot: • Lateral Column Lengthing (Evans Osteotomy) • Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy) • Calcaneal Slide Osteotomy Charcot: • Medial column fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot) • Lateral column fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot) In addition, the non-locking screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. The Pace Surgical Ultra r M Compression Screw System is intended for the internal fixation and stabilization of arthrodeses, osteotomies, fractures, and nonunions of the foot and ankle. The System is specifically indicated for: Fractures and Osteotomies • Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc) • Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture) • T alar fractures • Ankle fractures • Navicular fractures • Fractures of the fibula, malleolus, and calcaneus • Metatarsal and phalangeal osteotomies • Weil osteotomy • Calcaneal osteotomy Fusion resulting from neuropathic osteoarthropathy (Charcot), example: • Medial and lateral column • Subtalar, talonavicular, and calcaneocuboid Arthrodesis and Deformity Correction • 1st MTP arthrodesis • Metatarsal deformity correction • Tarsometatarsal joint arthrodesis • Naviculocuneiform joint arthrodesis • T alonavicular arthrodesis • Subtalar joint arthrodesis • Triple arthrodesis • Medial column arthrodesis • Subtalar joint distraction arthrodesis • Ankle arthrodesis • Lateralizing calcaneal osteotomy • Lateral column lengthening • Hammertoe Hallux Valgus Correction • Fixation of osteotomies (i.e. Akin, Scarf, Chevron) • lnterphalangeal (IP) arthrodesis • Proximal, midshaft, or distal osteotomy • Laoidus arthrodesis

Source page: https://510kreport.com/device/K261647
Methodology: https://510kreport.com/methodology